FDA 510(k) clearances — page 264
clearances on record, most recent first.
Clearances — page 264
26,301–26,400 of 175,699- K173468 — Aquilion Precision (TSX-304A/2) V8.6 with FIRST 3.0
- K173491 — RTS Lesser MTP Implant System
- K173493 — Amsco Evolution Floorloader Steam Sterilizer HC-2000 and HC-3000
- K173569 — Ultrasound System 1300
- K173677 — InMode VLaze
- K173689 — Ophthalmic Software Platform RX
- K173693 — Orbitum Bone Staple Implant, X and VI
- K173863 — Ez3D-i /E3
- K180130 — ELEOS Bipolar Acetabular System
- K171171 — KS Medicare Powder Free Nitrile Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs (Blue, Black)
- K171568 — SurFuse Gel, SurFuse Putty, ExFuse Gel, ExFuse Putty
- K171576 — The Panthera Anti-Snoring X3 Device
- K171649 — Straumann CARES M-Series CAD/CAM System
- K171823 — U&U Indicator tape and strip
- K171994 — Silicone Peripherally Inserted Central Venous Catheter Set/Tray
- K172294 — Osteotomy Truss System (OTS)
- K172541 — Medline Catheter Specimen Collector
- K173067 — LightForce LTS Model 1000, 1500, 2500, and 4000
- K173236 — Sentry IVC Filter
- K173255 — Talon DistalFix Humeral Nail
- K173334 — SeaSpine Spinous Process System
- K173381 — Nexxis OR
- K173402 — Neocis Guidance System (NGS) with Chairside Splint
- K173485 — Amsco Evolution Medium Steam Sterilizer
- K173490 — Amsco Evolution Medium Steam Sterilizer (Models HC-800 and HC-1000)
- K173967 — Remedy Acetabular Cup
- K180004 — Menicon ASRB (asmofilcon A) Silicone Hydrogel Soft Contact Lens
- K180181 — Natus Quantum
- K163377 — Captura Disposable Bronchoscope Biopsy Forceps
- K170866 — Scian Automatic Digital Blood Pressure Monitor, Model: LD-576, LD-575 & LD-579
- K171620 — PiCCO Catheter
- K172338 — Catasyn Advanced Technology Wound Hydrogel
- K172647 — Reprocessed ArthroCare ENT Coblator
- K172950 — TSN Transseptal Needle
- K173626 — Celerity 20 Steam Process Challenge Device for Dynamic Air Removal Cycles
- K173629 — CELERITY 20 Steam Process Challenge Device for Gravity Cycles
- K173963 — DRI Benzodiazepine Assay
- K180193 — DEKA SMARTXIDE Family (Smartxide Touch, Smartxide Punto)
- K170683 — Aesculap Video Assisted Thoracic Surgery (VATS) INstruments
- K171605 — Elecsys CA 15-3 II
- K172423 — PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry Central Venous Catheter (previously PreSep Oximetry Catheter)
- K172885 — HydroPICC
- K173228 — U-MED Powder Free Polyethylene Examination Gloves,Blue Color
- K173270 — Tri-Staple 2.0 Reinforced Reload
- K173513 — WS80A Diagnostic Ultrasound System
- K180176 — SeaSpine NewPort Spinal System
- K172390 — Optima Coil System
- K171521 — DUS R-50S (Urine Chemistry system)
- K171600 — Renal Access Cobra Catheter, Kumpe Access Catheter
- K171646 — ACISTCVi® Contrast Delivery System
- K172208 — NeVap Aspire Subglottic Suction Endotracheal Tube (ASSET) with Preloaded Stylet
- K172348 — AESKUSLIDES nDNA (Crithidia luciliae), AESKUSLIDES nDNA (Crithidia luciliae) Demo Kit, AESKUSLIDES nDNA (Crithidia luciliae) Bulk kit x5, AESKUSLIDES nDNA (Crithidia luciliae) Bulk kit x10
- K172361 — EEA Circular Stapler with Tri-Staple Technology
- K172934 — Needle Free Transseptal Cannula
- K173409 — Wireless Audio System
- K173460 — NeuroEEG
- K173587 — Magseed Magnetic Marker Systtem
- K180123 — Breast BI 7 MR Coil 1.5T Mammavention
- K180128 — Warrior 14 guidewire
- K180141 — SPIWay Endonasal Access Guide
- K171535 — SURGICAL ISOLATION GOWN
- K171604 — Rösch Thurmond Fallopian Tube Catheterization Set, Fallopian Tube Catheterization Set, and Fallopian Tube Catheterization Wire Guide with Platinum Tip
- K172613 — Optilite Hevylite IgG Kappa Kit, Optilite Hevylite IgG Lambda Kit
- K173212 — Instant-view-PLUS immunochemical Fecal Occult Blood Test
- K173288 — CorPath GRX System
- K173352 — Trevo Pro Vue Retriever and Trevo XP Pro Vue Retriever (Trevo Retriever)
- K173580 — Vinyl Patient Examination Glove (Yellow)
- K173636 — Velocity
- K173644 — Gazelle Polypropylene Suture and Delivery Device
- K173750 — Prelude IDeal Hydrophilic Sheath Introducer
- K173877 — BOWA Neutral Electrodes
- K180137 — AtriCure cryoICE cryo-ablation probe (CRYO3), AtriCure cryoICE cryoFORM cryo-ablation probe (CRYOF)
- K180138 — AtriCure cryoICE cryo-ablation probe (CRYO2)
- DEN170045 — Banyan BTI
- K172439 — Siberian Fit
- K173185 — SEURAT Universal Pedicle Screw System
- K173545 — TEMED Gas Diffuser
- K173565 — Sunrise 6200, Sunrise 7200
- K173567 — Sera
- K173651 — Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain Set
- K180158 — Surgical Laser fibers
- DEN170073 — ContaCT
- K171825 — Disposable Endoscopic Surgical Instrument, Reusable Endoscopic Surgical Instrument
- K172058 — CT6485, CT12885
- K172624 — Voyant 5mm Fusion Device
- K172839 — ENDOSOLV
- K172870 — Infra-red ear thermometer model: ET-100A, ET-100B, ET-100D, ET-100E, ET-100G, ET-100I, ET-100J
- K173195 — DRI Hydrocodone Assay
- K173313 — SupaChair Powered Wheelchair: COMBI 18, COMBI 18SP, COMBI 20, COMBI 20SP
- K173315 — SupaChair Powered Wheelchair
- K173535 — Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic Interbody Fusion Device and Endoskeleton® TCS Interbody Fusion Device
- K173592 — MAGNETOM Aera, MAGNETOM Skyra/Skyrafit, MAGNETOM Prisma/Prismafit, MAGNETOM Avantofit
- K180288 — QuickVue Influenza A+B
- K170793 — SuRgical Planner (SRP)
- K171495 — Zyston Strut Open Titanium Spacer System
- K171933 — ASAHI PTCA Guide Wires, ASAHI Corsair Microcatheter, ASAHI Corsair Pro Microcatheter
- K172775 — MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip Handle
- K172883 — Home Use Hair Removal Device/T1, T2, T3
- K172941 — CASCADIA Interbody System
- K173527 — Digitex Delivery Device
Data sourced from openFDA. This site is unofficial and independent of the FDA.